Largest ever whole-of-population study on the impact of TB and HIV interventions on the burden of TB launched in sub-Saharan African communities

Friday, 23 March 2018 (London, UK) – A new EUR 12.9 million project has been launched, measuring the impact of a combination TB and HIV intervention when delivered to the entire population of 14 urban, high-prevalence communities in South Africa and Zambia.

TB and HIV are the leading infectious causes of death worldwide – in 2016 1.7 million people died of TB. For people living with HIV, TB is the most significant co-infection, 40 percent of HIV deaths in 2016 were due to TB. The TREATS project [Tuberculosis Reduction through Expanded Anti-retroviral Treatment and Screening] was developed in response to this.

“TREATS is a unique opportunity to assess a combined TB and HIV intervention on a massive scale,” said Dr Helen Ayles, TREATS Project Director, Professor of Infectious Diseases at London School of Hygiene & Tropical Medicine and Research Director at Zambart. “It will provide amazing data and hopefully some practical solutions to end TB. TB is a curable illness, but in order to better reach people with treatment, we need to understand the epidemiology of the disease better. This is true active case-finding.”

TREATS aims to inform new policies and approaches for tackling the TB / HIV epidemic. As the global health community works towards ambitious new goals to end TB, TREATS will provide invaluable new information for accelerating effective interventions.

TREATS is being conducted by a consortium of organisations that is already running the largest ever trial of a combination HIV prevention strategy, known as HPTN 071 (PopART). This trial is being conducted across 21 communities in Zambia and South Africa, covering around one million people in total. PopART involves universal testing and treatment for HIV through house-to-house visits on an annual basis over four years – from 2014 – 2018. As part of PopART, all community members are also screened for TB.

Building on PopART, TREATS will measure the impact of this combined TB / HIV intervention on tuberculosis – measuring prevalence of disease as well as incidence of infection. The project runs until 2021 and includes: a social science component to better understand stigma related to TB; mathematical and economic modelling to provide answers for how future large-scale interventions can be undertaken effectively; use of the newest tools available for diagnosing TB infection and operating effectively on a large scale.

It was International Awareness Week for the Deaf from September 18 through 25, 2017 and Zambart’s largest on-going study, the HPTN 071/PopART trial participated in the commemorations spearheaded by the Zambia National Association for the Deaf (ZNAD). The activities were aimed at highlighting the skills and challenges of the hearing impaired people in local communities, places of work, and public spaces.

Prior to the commemoration, a Zambart research team in Kanyama, Lusaka, one of the study communities, decided to create more impact to assist more people access the life-saving HIV antiretroviral treatment (ART) and prevention services, and contribute to their quality of lives. Kanyama is one of the 12 communities for Zambart’s largest clinical trial – the HPTN 071 (PopART) study. Six members of the PopART intervention team from Kanyama site were among the 17 students that completed basic training in sign language. The Kanyama PopART lay health counsellors called Community HIV Care Providers (CHiPs) become the second group to integrate sign language into their house-to-house HIV Testing and Counselling (HTC) delivery.

Kanyama District Intervention Coordinator (DIC) Louis Mwape, said field teams were motivated to take the sign language course because they encounter hearing and speech impaired people in the community and fail to communicate with them. “We have many cases where our CHiPs meet clients who only understand sign language, and until now we only had one counsellor who had undergone basic sign language training and she would often be called upon to help her colleagues. The hospital also called her to help with communication between medical personnel and deaf patients. This was affecting her work in her zone.”

In 2015, the PopART intervention team in Makululu, Kabwe (Central Province), also adopted a similar strategy in order to include the hearing and speech impaired people in the community with the PopART intervention package.

The skills acquired by the CHiPs will also be extended to Kanyama First Level Hospital where PoPART study clients access various HIV and TB treatment and prevention services. The CHiPs will assist hearing and speech impaired patients including those referred to the hospital through the PopART intervention. “In this way, PopART will work in line with the theme for this year “Full Inclusion with Sign Language,” said Mwape.

Mwape said the training center for the hearing impaired has requested the Zambart team in Kanyama to send CHiPs to the facility and offer HCT services and link into care clients there with speech and hearing impairment. He added that the teams’ services will now be more comprehensive as they intensify the intervention mop up.

PopART Intervention Manager of Volunteer Medical Male Circumcision and TB, Ephraim Sakala, explained that Zambart in its work and activities desired to ensure that all people receive health services regardless of their condition. “The hearing impaired people need information on HIV/AIDS and TB so that they also can make informed decision on their health.” He said the knowledge and skills acquired by CHiPs in Basic Sign Language will help PopART study reach more people who may have been neglected through dissemination of awareness raising information.

At the site where the commemorations event was held, the PopART erected a tent from where they conducted HCT services and provided health information to over 40 people.

The HIV Prevention Trials Network (HPTN) 2017 annual meeting brought together researchers from its clinical trials involved in HIV prevention in countries across the world. Zambart, is part of a consortium of international researchers currently conducting the world’s largest HIV prevention trial in 21 communities in Zambia and South Africa.

The Zambart Community Engagement (CE) team on the HPTN 071(PopART) Trial won the Best Community Engagement Award for outstanding performance in mobilising the biggest community randomised HIV prevention study in the world. During the course of the four year study, Zambart’s CE team has developed novel strategies to engage, sustain, and work together with other study groups to increase participants for the trial, including ancillary studies nested with the main trial.

During the last PopART study all-staff training the various teams had an opportunity to share their personal experiences and reflects about the trial. The field teams, on whom the successful implementation of the study relies heavily, had some great feedback about PopART. Equally the supervisors and technical leaders who support the field teams and enable them to boldly carry out their work had a few things to say.

Here are just a few examples of some of the PopART staff reflections from the field and head office alike:

“When you change a life, you change a life forever,” – Steve Belemu, Zambart Community Engagement Team

“The HPTN 071 is an extraordinary study, and we did it, each and every one of you.” – Dr Helen Ayles, PopART Site Principal Investigator: Z Director of Research- Zambart

“PopART has been an amazing study. It has successfully managed to mobilise efforts of different people, organisations and communities towards the dream of achieving an HIV free Zambia. Yes, it is possible to get rid of HIV if we replicate PopART at country level.” – Dr Musonda Simwinga, Zambart Community Engagement Lead & Social Scientist

“I first became involved in HIV research in 1985. The lab I was in was among those conducting the initial trials of AZT, which became the first drug approved for treatment of individuals infected with HIV. Three decades later, PopART is demonstrating the efficacy of treatment as prevention at the population level. It’s gratifying to be a part of the PopART team and the remarkable advances that have been made in HIV treatment.” – Barry Kosloff, Head of Zambart Laboratories

“One day we went in the field and enrolled a female participant whose husband had died some years before. She wanted to know her HIV status. The research assistant consenting the woman and I was called to collect the sample. After the test was done, she was found to be reactive and we linked her to care. She then asked if I could also test her daughter who was not looking too healthy and she also tested reactive. We linked her to care too. From that time to date, this family is like my family to me. I feel happy when I pass by their home and see how happy they are and getting on with their life.” (PopART CHiP)

“I tested a man in a household that I had been visiting in my zone, he tested HIV positive but it was very difficult to link him to care. When he fell very ill, that is when he started the treatment and he is now doing fine. And after that, his mother disclosed that she was also taking care of a child who lost its mother at a very young age. I probed more and asked if I could test the child. The test was positive and I managed to link the child to care. The child looks good and feels good now. She doesn’t get sick like before. This makes me happy and am proud of myself at least I have saved a life.” (CHiP)

In other bizarre experiences shared by the PopART intervention team staff: A female CHiP reflected how a client insisted to the PopART team visiting his household that he was born naturally circumcised and attempted to show them. And in another instance, a client attempted to remove all his clothes off to show the CHiP team during a household visit a skin rash that had spread all over his body. Some of the CHiPs narrated how at the beginning of the study they would sometimes be mistaken for political cadres. Another CHiP recalled a field encounter when instead of conducting HCT they found themselves as first responders to an expectant woman’s call for help and helped to conduct a home delivery, after which they assisted the woman to the health facility for onward care.

“In year one we tested the wife in absence of the husband and the results were negative. Shortly afterward, the husband came and the wife asked the husband to also test but with a warning that if her results came out positive that would be the end of their marriage. Later, the wife left the house to go to the market and the husband asked to be tested in the absence of the wife and he tested HIV positive.

In year two, we went back to the household and tested the wife again. She tested positive. But she could not understand how she could be positive when her husband was negative (the husband had told her that he tested negative when in actual fact he was positive). The wife refused to start treatment fearing the husband who thought she was negative. The husband-had refused to start treatment for fear of being divorced by the wife who he believes was negative.”- (CHiP)

“In annual round two, I went to a household where I tested a seven (7) year old girl and she was reactive. Unfortunately, she was not linked to care because her father’s family said that she was too young to be HIV positive, and the girl’s mother’s relatives insisted her mother died of witchcraft and not HIV. In annual round three, I learned that they had not yet linked her to care because of the misunderstanding and beliefs from the two families. This matter was reported to the supervisor and the youth counsellor but to no avail. Eventually the girl got very ill and that is when they cousin decided to take her to the clinic. The file was opened for the girl. As I.mm writing, the girl’s condition has improved.” – (CHiP)

“A 13 year old client told me that he was denied condoms, so he only picks the used condoms, washes them and then use them. The CHiP advised him not to pick used condoms because they are contaminated. He was counselled on abstinence ad tested for HIV and condoms were given to him.”- (CHiP)

In delivering the house-to-house PopART HIV prevention package in the various study communities, the field teams comprised of Community HIV Care Providers (CHiPs); Research Assistants; Research Nurses; Community Mobilisers; worked in collaboration with community leaders and health facilities. Over the course of the four years of study implementation, PopART staff forged great friendships and further strengthened the nearly 3 decade old partnership Zambart has had with the communities.

Thanks to everyone for their support, dedication, and teamwork that continues to make Zambart a solid community-focused local research organization working to improve health for all Zambians.

On August 8-11, about 700 staff members on the HPTN 071 (PopART) trial in Zambia, gathered in the small resort fishing town of Siavonga, south of the capital Lusaka, for their last annual refresher training and retreat before the end of study intervention activities later in December 2017. Organizers brought together all the study staff from the 12 PopART sites, including central Zambart office in one place. This was a huge undertaking by the study leadership and Zambart management.

The PopART trial is the world’s largest community randomized HIV prevention study involving an estimated 1.2 million people in 21 large population communities in two Southern African countries: Zambia and South Africa. Since 2013, international and Zambian researchers have been measuring the impact of combined HIV prevention intervention methods including universal testing and treatment and door-to-door HIV Counselling and Testing, and active referral.

The training included team building sessions. Team leaders and managers mentored Community HIV Care Providers (CHiPs) in delivery of the final study messages to prepare communities for the end of the study, data collection, orientation in HIV Self-testing, and reviewed enrolment of households participating in the study. Population Cohort (PC) and Phylogenetics scientists and technologists reviewed the upcoming final round of PC activities and Xpert Tuberculosis (TB) testing including other laboratory based activities and protocol training. The r Social Science team reviewed stigma tools for the qualitative cohort and activities conducted under the PopART Story of the Trial.

Zambart Chief Executive Officer Dr Alwyn Mwinga commended the PopART study team in Zambia for their dedication to delivering a complex study such as PopART, through the work that they do.

We have achieved what we set out to do. This study must be written up and put in history books because it is such an interesting research,

she said during the formal opening of the training.

Site Principal Investigator Dr Helen Ayles said that the PopART trial was an extraordinary study and was by far the biggest study on HIV prevention ever done. She thanked all the study staff for their hard work and dedication,

You have been amazing, and I want to thank you for such a job well done. This is something that can be rolled out at national scale.

Dr Ayles, explained to the study team the forthcoming end of study intervention activities on 31st December, 2017.

“This has always been a study and we have always had a limited life span. You have managed to reach more young people, and more individuals who had previously not tested for HIV,”

she said, and unveiled plans for continued lower level PopART intervention related activities. These included the on-going Community ART, HIV Self-Testing and measuring the prevalence of TB in PopART.

“It is going to be different, but there will still be research activities going on in our sites after the PopART intervention end, for example we will also do more work with adolescents and in social science,”

Dr Ayles said.

Trainers used the opportunity of having everyone together to reflect on the various challenges, experiences and lessons learned by the different study teams during the course of the trial. This generated a deep introspective discussion and brought out poignant aspects of the trial. This was colorfully depicted through the building of the gigantic PopART study reflection tree. This was a hands-on and exciting time for all study staff. The study teams received awards in various categories and concluded the training on a high note in select sporting activities such as soccer, volley ball and boat cruises on Lake Kariba.

Adding HIV self-testing as an additional option to a door-to-door programme offering HIV testing in Zambia boosted the uptake of HIV testing among men, younger adults and those who had previously refused HIV testing, Helen Ayles of the London School of Hygiene and Tropical Medicine told the 9th International AIDS Society Conference on HIV Science (IAS 2017) in Paris today. It appears that HIV self-testing may have a particular impact on testing rates in men and could contribute to meeting the 90-90-90 targets in men.

Ayles emphasised that the effect was seen in communities which had already been exposed to three years of intensive efforts to offer HIV testing to all. People who had not already been tested must be considered the ‘hardest to reach’ and the self-testing intervention was notable for having an impact with these individuals.

The study presented was a substudy of PopART (also known as HPTN 071), a large community-randomised trial being carried out in high-prevalence communities in Zambia and South Africa. PopART is aiming to implement an approach of universal HIV testing and universal access to immediate HIV treatment for those who need it, in order to reduce new HIV infections.

The main approach to HIV testing used in PopART is home based HIV testing, in which lay counsellors (known in the study as Community HIV Care Providers or CHiPs) systematically visit all households in a geographical area and offer HIV testing and counselling. While this approach is feasible and acceptable, it is challenging to achieve very high levels of uptake among men, younger people and mobile individuals (for example, people travelling for work).

By the end of the second year of PopART, the target of having tested 90% of people had been achieved for women, in almost all age groups over 20 years (but not for younger women). But uptake was much lower in men – in most age groups, between 70 and 85% had tested, with uptake only surpassing 90% in those over the age of 55.

Supplementary approaches appear to be necessary.

A substudy of PopART therefore aimed to evaluate whether offering self-testing as an additional option would increase the uptake of HIV testing. This was a cluster-randomised trial in 66 zones in four communities in Zambia. In the 33 intervention zones, household members were offered two options for HIV testing – rapid testing by the lay counsellor or self-testing. In the 33 zones in the control group, only rapid testing by the lay counsellor was offered.

The standard PopART intervention, offered in the control group, involves lay counsellors making door-to-door visits to households and offering rapid HIV testing, using a finger prick blood test. The lay counsellors also test for sexually transmitted infections and tuberculosis, as well as promoting and making referrals to treatment and male circumcision services. They also provide support for retention in care and adherence to treatment.

In the arm of the study in which self-testing was an option, it was chosen by 55% of those who took a test. The vast majority (88%) of those taking a self-test chose to have the lay counsellor present during the test, described as ‘supervised’ self-testing by the researchers. The health worker could help with problems users faced in operating the test or in interpreting the result. Helen Ayles said that she would expect more self-testing to be unsupervised in the future, as people become more familiar with the process.

Another testing modality was ‘secondary distribution’ — when a household member was absent, a self-testing kit could be left with their partner for them to use later.

By the end of a three-month period earlier this year, 60.4% of adult men in the intervention arm knew their HIV status, compared to 55.1% in the control arm. A similar effect was not seen in women.

The effect of providing self-testing was also seen in people of both genders aged 16 to 29 (73.5% in the intervention arm and 70.2% in the control arm knew their status).

There was also strong evidence that providing self-testing improved knowledge of status in individuals who were locally resident during earlier phases of PopART but had previously turned down the offer of testing by the PopART lay counsellors. Among these individuals, 29.7% knew their status in the intervention arm, compared to 20.6% in the control arm.

In the control arm, 2.6% of people testing had reactive results. The figure was similar for people tested by the lay counsellor in the intervention arm (2.5%), people using self-tests with supervision (2.9%) and people using self-tests without supervision (3.5%).

However, it was noticeable that in people tested following secondary distribution (i.e. partners who were absent when the lay counsellor visited), the numbers with reactive results were higher. In 81 people who discussed their results with the lay counsellor, 9.9% had a reactive result and in 242 people whose results were communicated by the partner to the lay counsellor, 5.4% had a reactive result. Secondary distribution may be particularly helpful in reducing undiagnosed infection. In many cases, it led to the couple testing together.

Qualitative findings from in-depth interviews and focus groups suggested that self-testing was acceptable for people who were worried about waiting times and stigma in clinics; self-testing had advantages in terms of confidentiality, control and convenience; and that people felt empowered by knowing how to test themselves. Self-testing was particularly acceptable for busy and mobile people, married men, those living with a partner, people of higher social classes, those in formal employment and members of key populations (such as sex workers).

Helen Ayles said that HIV self testing is a solution for engaging ‘hard-to-reach’ groups such as working men and mobile populations with HIV testing. She said that even if the increase in testing uptake may be modest (a few percentage points), this should be considered in the context of a population that has already been given multiple opportunities to test.

What is your research process for the social science aspects of PopART?

I work with a core team. We have Zambian and South African social scientists who we’ve recruited and done a lot of training with. In the sites where we’re doing interventions, we have local social science research assistants who are residents of that place. When we go to those communities, we work with them. READ MORE…

Principal Investigator, for the Self-Testing Africa Project (STAR) Dr Helen Ayles, on June 8 2016, joined the Clinical Performance Study (CPS) team in M’tendere Township, in Lusaka, one of the study sites of the project. The two-year programme funded by UNITAID to provide cost-effective solutions for expanding existing HIV testing services, is being conducted in Zambia, Malawi, and Zimbabwe.

Dr Ayles, who is the Zambart Research Director, wanted to get a hands-on view of how the Clinical Performance Study is being carried out and to learn some of the field challenges staff are experiencing. She also observed how participants conduct the self-test using the provided OraQuick® HIV self-test kit, and how they read and record their own results.

The study will determine whether oral fluid HIV self-tests can be used effectively and read accurately across different populations in Zambia. The study will compare the results of oral fluid tests with a laboratory-based blood test to determine the sensitivity and specificity (ability of the test to pick out true positives as positives (Sensitivity), and to pick out only the HIV anti-bodies specifically (Specificity). Further, CPS aims at establishing the accuracy of the HIV self-test when used by intended users, who include: adolescents and adults in urban and rural Zambian settings.

Captured in the picture above, Dr Alyes, looks on as a CPS Research Assistant, Debbie Sibayuni, enters data into an Electronic Data Capturing device, collected from a study participant in Kalikiliki area, a densely populated compound on the outskirts of M’tendere community. The client is asked questions about the self-test after she performed an HIV self-test using OraQuick®.

OraQuick® is being piloted in M’tendere and Kanakantmpa communities in Lusaka and Chongwe districts respectively, to determine the acceptability of HIV self-testing. Self-testing can help to reach those who are unable to access HCT services because of various social, cultural and geographical challenges, and encourage re-testing among those at high-risk. It can also help to reach those unlikely to use current HIV testing services because of privacy issues or lack of convenience.

Zambart has engaged with a consortium of researchers and implementers to provide research expertise in Zambia for the use of HIV self-tests in populations with the greatest need. The consortium is led by Population Services International (PSI) led collaboration, which includes the Ministry of Health, and Society for Family Health as the main distributors of the OraQuick HIV Self-Test kits. Other partners ion the STAR project are the London School of Hygiene and Tropical Medicine (LSHTM), the Liverpool School of Tropical Medicine (LSTM), University College London, and the World Health Organisation (WHO), and the Ministry of Health.

The Self-Testing Africa(STAR) Study is a three-country research namely: Malawi, Zambia and Zimbabwe, and is funded by UNITAID. In Zambia the study partners are Society for Family Health (SFH), Population Service International (PSI), Zambart, London School of Hygiene and Tropical Medicine (LSHTM), and Liverpool School of Tropical Medicine (LSTM).

The aim of the study is to catalyse the HIV Self-Testing market in Malawi, Zambia and Zimbabwe by testing innovative market interventions and strengthening evidence base around the effective use of HIV rapid diagnostic tests (HIV-RDT), through formative and evaluative research. The primary objective is to increase the uptake of quality assured HIV Self-Testing among the general urban and rural population.

On April 7-8, 2016, Zambart held a 2-day orientation for STAR study staff aimed at equipping the Research Nurses and Research Assistants on Good Clinical Practice in Research and the steps to follow when recruiting participants for the Oral HIV Self-testing using Ora Quick HIV Testing Kits.

Zambart is conducting the clinical performance study in Lusaka at Mtendere Clinic, and in Chongwe district in Kanakantapa community. This will be done over a 12-month period. Meanwhile, the impact assessment of the STAR study will be conducted in 4 centres in Kapiri Mposhi (central Zambia) namely: Chankomo; Nkole; St. Pauls, and NCDMS. In Ndola (Copperbelt) at Lubuto and Twapya clinics; in Lusaka at Ngombe and Bauleni clinics, and in Choma (southern Zambia) at Mbabala, Mapanza, Sikalongo, and Batoka clinics.